Status:
COMPLETED
RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced and Metastatic Silent Neuro-Endocrine Tumors
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥ 18 years old
- Patients with advanced (unresectable or metastatic) biopsy proven non-syndromic neuro-endocrine carcinoma, low or intermediate grade
- Radiological documentation of disease progression within 12 months prior to study entry. If patients received anti-tumor therapy during the past 12 months, they must have radiological documentation of progressive disease (PD) while on or after receiving the therapy
- Patients may have received previous treatments (chemotherapy, biotherapy, peptide-receptor radionuclide therapy); an overall maximum of 3 systemic treatment is allowed
- Patients with at least one measurable lesion
- Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Adequate lipid profile
- Exclusion criteria:
- Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
- Patients with carcinoid with hormone related symptoms (diarrhea ≥ 4 stools per day and/or flushes)
- Patients with Islet cell carcinomas or pancreatic NET
- Patients who received prior therapy with Vascular Endothelial Growth Factor (VEGF) pathway inhibitor within 4 weeks prior to study entry
- Patients who entered peptide receptor radionuclide therapy (PRRT) within 3 months prior to study entry
- Patients who received CT, biotherapy or radiotherapy within 4 weeks prior to study entry
- Patients who have previously received systemic (mammalian target of rapamycin) mTOR inhibitors
- Patients with a known hypersensitivity to everolimus or other rapamycins or to its excipients
- Patients with uncontrolled central nervous system (CNS) metastases
- Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent
- Patients with a known history of HIV seropositivity
- Patients with autoimmune hepatitis
- Patients with an active, bleeding diathesis
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
- Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start
- Patients unwilling to or unable to comply with the protocol
Exclusion
Key Trial Info
Start Date :
June 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2016
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00688623
Start Date
June 24 2009
End Date
November 7 2016
Last Update
January 25 2019
Active Locations (40)
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1
Novartis Investigative Site
Bordeaux, France
2
Novartis Investigative Site
Lyon, France
3
Novartis Investigative Site
Marseille, France
4
Novartis Investigative Site
Paris, France